MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MI CALCAR REAMER SHAFT; HIP INSTRUMENTS : REAMERS

Catalog Number	257004500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that when calcar reaming over a size 5 actis broach the trunion of the broach snapped off within the calcar miller.The broach became stuck in the bone and a burr and vice grips were needed to extract the broach.This added about 20 minutes to surgery.All pieces were retrieved.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H11 additional narrative: added: a2.
Additional Manufacturer Narrative
The device malfunction, device interaction (2+ devices) : jammed/seized, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that when calcar reaming over a size 5 actis broach the trunion of the broach snapped off within the calcar miller.The broach became stuck in the bone and a burr and vice grips were needed to extract the broach.This added about 20 minutes to surgery.All pieces were retrieved.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.Mi calcar reamer shaft was returned disassembled and it only shows normal signs of use.A functional test was performed with a laboratory sample mating device, and the modular calcar planer sml was successfully assembled without any issues.There were no difficulties observed during assembly and disassembly.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the mi calcar reamer shaft would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative: corrected: h3.

• Brand Name: MI CALCAR REAMER SHAFT
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22470427
• Report Number: 1818910-2025-11822
• Device Sequence Number: 20953700
• Product Code: HTO
• UDI-Device Identifier: 10603295143192
• UDI-Public: (01)10603295143192(10)AG2184711
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 257004500
• Device Lot Number: AG2184711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/06/2025; 08/14/2025; 09/01/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/06/2025; 08/19/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female